Are you developing inhaled Cannabinoid formulations for delivery by metered dose inhalers (MDI), dry powder inhalers (DPI) or Soft Mist Inhalers (SMI)?
The EMA recommend that to characterise the effectiveness of an inhaler’s delivery, the following testing is commonly performed:
- Delivered dose uniformity testing is to ensure that the inhaler performs throughout the container’s life from first dose to last dose. It is generally expected that at least ten doses from the combination of the beginning, middle, and end of the container be tested.
- Fine Particle Dose Fraction Testing is used to characterise the aerodynamic particle size of inhaled products using an impactor. This is because they directly measure aerodynamic size, which is the most relevant parameter to describe particle transport within the respiratory tract. Individual stage particle size distribution data should be provided using a multi-stage impactor.
- Mouthpiece deposition testing. The amount of drug deposited on the actuator or mouthpiece should be determined and, where applicable, to demonstrate consistency with label claims.
- Initial priming testing to support the number of actuations recommended in the labelling to be fired to waste (priming actuations) prior to the consumer using the device. Including re-priming testing to support the length of time a device can be stored prior to re-use.
- Cleaning requirements in accordance with recommendations for priming, dosing intervals, and typical dosing regimen.
- Temperature cycling testing performance and the performance under varying moisture regimes.
- Microbial testing to demonstrate no ingress under use and the effectiveness of preservatives.
If your company is researching the medicinal properties of Cannabinoids delivered by inhalation Tepnel Pharma Services hold schedules 1, 2, 3, 4 part I, 4 part II and schedule 5 controlled drugs licenses, along with experience and capabilities in testing Cannabinoid formulations, and inhalation device testing. We support pharmaceutical research and development from preclinical enabling stability and formulation selection through to batch release testing into the market-place.
For more information on how we can support your project please leave your details below and a member of the team will be in touch.
- EMA Guideline on the pharmaceutical quality of inhalation and nasal products 21st June 2006 EMEA/CHMP/QWP/49313/2005
- Mitchell JP, Nagel MW.J Aerosol Med. 2003 Winter;16(4):341-77. doi: 10.1089/089426803772455622.PMID: 14977427